Category Archives: Basal Insulin

Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Thoughts on Newly Permanent Lilly Insulin+Baqsimi Copay Cards; New Novo+ACC ASCVD Registry; ProSciento Receives VC Investment

A series of diabetes-related news items have been observed: Lilly permanently committed to the Insulin Value Program $35 copay card besides other savings options for Humulin R U500 and Baqsimi; Novo Nordisk and ACC are launching a new ASCVD T2DM registry; and ProSciento closed a venture capital funding round. Below, FENIX provides an overview of the respective news items as well as thoughts on the economic benefit of the $35 insulin copay card compared to Semglee in addition to how the ACC partnership is beneficial to Novo.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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New Tirzepatide + Glargine U100 vs. Basal-Bolus Trial (SURPASS-6)

A new CT.gov record has been observed for a Lilly-sponsored Ph3 trial (SURPASS-6) comparing the safety and efficacy of tirzepatide vs. insulin lispro U100 in T2DM patients inadequately controlled on glargine U100 with or without metformin. Below, FENIX provides an overview of SURPASS-6 as well as insight into why the trial makes sense in the context of similar LCM trials conducted for Ozempic, Trulicity, Tanzeum, and Bydureon.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon/Mylan Launch Semglee in US at 65% WAC Discount to Lantus

Biocon/Mylan announced the US launch of its Semglee 10mL vials and pre-filled pens (glargine U100) at a 65% discount to Lantus. According to Biocon/Mylan, the WAC for a package of 5 x 3mL pens is $147.98 and a 10mL vial is $98.65. Interestingly, Biocon/Mylan said the Semglee pen price matches the Lantus 2007 WAC and the Semglee vial list price matches the Lantus 2010 price. Below, FENIX provides a comparative pricing analysis across the basal insulin market, the Semglee launch implications to Sanofi and Lilly, and thoughts on how the Biocon/Mylan strategy may impact other bs-glargine manufacturers (e.g. Sandoz/G&L and Lannett/HEC).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lannett To Forego Bs-Glargine U100 Interchangeability; Lannett Q2 ’20 Earnings Update

Yesterday, Lannett (press release) hosted its CY Q2 ’20 (FY Q4 ’20) earnings call and provided updates to its biosimilar glargine U100 development and regulatory plans. Importantly, Lannett disclosed that its bs-glargine U100 strategy is to forego interchangeability and compete as an “affordable alternative.” Below, FENIX provides highlights and insights from the call, including thoughts on Lannett’s strategy as the 5th-to-market bs-glargine U100 in the US.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

AZ to Withdraw Qtrilmet Marketing Authorization; CHMP Agenda August 17-20

The CHMP agenda for this month’s meeting (August 17-20) has been released, and it includes one notable item: Qtrilmet marketing authorization withdrawal. Of note, the August 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on August 17. Additionally, the August CHMP meeting does not include oral explanations, only written procedures. Below, FENIX provides diabetes-related highlights and insights from the August 2020 CHMP agenda.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Novo Invests in Upgrading Kalundborg Manufacturing Facility

Novo Nordisk announced an investment of DKK 850M (~$135M USD) into expanding its production site in Kalundborg, Denmark. According to the press release, Novo manufactures half of the world’s insulin supply and carries out the assembly and packaging of diabetes and biopharm products at this site. This most recent investment brings Novo’s 2020 Kalundborg investments to nearly $318M USD. Below FENIX provides thoughts on the manufacturing investment in the context of the potential products it could support.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo Q2 ’20 Roadshow; Provention Bio Q2 ’20 Earnings Update; Senseonics Eversense Covered by Highmark

Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and earnings calls.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Mylan Filed for Glargine Interchangeability; Insulet, Mylan, and BD Q2 ’20 Earnings Updates

Mylan (press release; slides), Insulet (press release), and Becton Dickinson (press release; slides) hosted their respective Q2 ’20 earnings calls. Of note, Mylan disclosed it has submitted “all necessary documentation to seek biosimilar interchangeability [for Semglee]” as well as a BLA for its bs-aspart with FDA. Below, FENIX provides highlights and insights from the respective earnings calls.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo Discontinues its Dual/Triple Agonists for Obesity; Novo Q2 ’20 Earnings Update

Novo Nordisk hosted its Q2 ’20 earnings call (press release; slides) and provided updates to its diabetes, obesity, and NASH clinical and commercial activities, but much of the discussion was focused on Novo’s obesity portfolio. Importantly, Novo disclosed it has discontinued the development of its dual and triple agonists for the treatment of obesity following positive results from the recent semaglutide and AM833 data disclosures (semaglutide Ph3 STEP, Ph2 AM833, and Ph1 sema+AM833). Additionally, FENIX includes context from Novo’s invite-only R&D event on June 19 (view slides here). Below, FENIX provides highlights and insights from the call, including why it makes sense Novo would use its PRV for semaglutide in obesity.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.